Chronic Kidney Disease; Iron Deficiency AnemiaPhase 3NCT03619850
A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)
A Phase 3 study testing Ferumoxytol and Iron sucrose in people with Chronic Kidney Disease; Iron Deficiency Anemia, run by AMAG Pharmaceuticals, Inc. at 21 sites in 5 countries.
Trial summary
Primary Objectives: To evaluate the safety (compared to iron sucrose) and efficacy of ferumoxytol in pediatric CKD subjects with iron deficiency anemia (IDA) or who are at risk of development of IDA Secondary Objective: To determine the single-dose pharmacokinetics (PK) and pharmacodynamics (PD) profile of ferumoxytol… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Chronic Kidney Disease; Iron Deficiency Anemia
- What is being tested?
- Ferumoxytol and Iron sucrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 21 sitesin 5 countries
- Study dates
- 13 Aug 2018to 31 Aug 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female 2 years to <18 years of age at time of consent
- Has IDA defined as: a) hemoglobin <12.0 g/dL and b) with either transferrin saturation (TSAT) <40% or ferritin <100 ng/mL; or considered to be at risk of development of IDA, i.e., TSAT<20% with falling hemoglobin during the preceding 2 months and a history of hemoglobin <12 g/dL
- Has Chronic Kidney Disease defined as one of the following:
- on chronic hemodialysis;
- receiving chronic peritoneal dialysis;
- estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m2;
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- has evidence of structural and/or functional abnormalities e.g., persistent albuminuria, abnormal urine sediment, electrolyte and other abnormalities due to tubular disorders for > 3 months.
- For patients other than hemodialysis dependent CKD patients, documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate
- All subjects (female and male) of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to Day 1 Dosing and agree to remain on birth control until completion of the study
Who cannot join
- Known hypersensitivity reaction to any component of ferumoxytol and iron sucrose
- History of allergy to intravenous (IV) iron
- History of multiple drug allergies (>2)
- Low systolic blood pressure (Age 1-9 years <70 + [age in years x 2] mmHg, Age 10-17 years <90 mmHg)
- Hemoglobin ≤7.0 g/dL
- Serum ferritin level >600 ng/mL
Trial locations and contacts
21 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 5 countries
United States8 sites, 6 recruiting
- Recruiting
Akron Nephrology Associates, Inc.
Akron, Ohio, 44302
- Active, not recruiting
Wayne State University
Detroit, Michigan, 48201
- Not yet recruiting
Memorial Healthcare System
Hollywood, Florida, 33021
- Recruiting
Children's Mercy Hospital
Kansas City, Missouri, 64108
- Not yet recruiting
The Feinstein Institute Medical Research Organization of Northwell Health, Inc.
Lake Success, New York, 11042
- Recruiting
West Virginia University
Morgantown, West Virginia, 26506
- Active, not recruiting
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
New York, New York, 10029
- Recruiting
Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)
The Bronx, New York, 10467
Mexico4 sites, 3 recruiting
- Recruiting
Instituto Mexicano De Trasplantes S.C
Cuernavaca
- Active, not recruiting
JM Research, SC
Cuernavaca
- Recruiting
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara
- Recruiting
Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)
Mexico City
Poland4 sites, 3 recruiting
- Not yet recruiting
Uniwersytecki Szpital Kliniczny Im. Zamenhofa w Bialystoku
Bialystok
- Active, not recruiting
Specjalistyczne Gabinety Sp. z o.o
Krakow
- Not yet recruiting
University Children Hospital
Krakow
- Not yet recruiting
Polish Mother's Memorial Hospital Research Institute
Lodz
Lithuania3 sites, 2 recruiting
- Not yet recruiting
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas
- Active, not recruiting
Klaipeda Children's Hospital
Klaipėda
- Not yet recruiting
Vsl Vilniaus Universiteto Vaiku Ligonine (VUVL) (Vilnius University Children's Hospital)
Vilnius
Hungary2 sites, 2 recruiting
- Recruiting
Semmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK) - I. sz. Gyermekgyogyaszati Klinika
Budapest
- Recruiting
University Of Szeged
Szeged
About this study
Official title: A Phase 3, Randomized, Open-Label, Multicenter Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)
Primary Objectives:
To evaluate the safety (compared to iron sucrose) and efficacy of ferumoxytol in pediatric CKD subjects with iron deficiency anemia (IDA) or who are at risk of development of IDA
Secondary Objective:
To determine the single-dose pharmacokinetics (PK) and pharmacodynamics (PD) profile of ferumoxytol in pediatric subjects.
Read the detailed description
This is a Phase 3, randomized, open-label, multicenter, study of the safety (compared to iron sucrose), efficacy, and PK/PD of ferumoxytol (7.0 mg Fe/kg x 2 [max 510 mg/dose]) in pediatric subjects with iron deficiency anemia (IDA) and CKD. There will be a total of approximately 125 subjects randomized to treatment in a 2:1 ratio to either ferumoxytol or iron sucrose.
Total subject participation in the study will be up to 7 weeks, which includes a 2-week Screening Period and a 5-week Treatment Period.
Subjects receive the following:
- Two IV infusions of ferumoxytol 7.0 mg Fe/kg (max 510 mg/dose), the first administered on Day 1 and the second 2-8 days later
OR
- Iron sucrose (Venofer®): For Hemodialysis Dependent (HDD) patients: 2 mg Fe/kg, administered on consecutive dialysis sessions, for 10 doses (max 100mg/dose with a total max treatment course of 1000mg) For Non-hemodialysis Dependent (NDD) or Peritoneal Dialysis De pendent(PDD) patients: 4 mg Fe/kg, administered up to 3 times/week, for 5 doses (max 200mg/dose with a total max treatment course of 1000mg).
- Being tested
- Ferumoxytol, Iron sucrose
- Keywords
- Iron deficiency anemia (IDA), chronic kidney disease (CKD), pediatrics, ferumoxytol, iron sucrose, Feraheme, Venofer
- Medical subject headings
- Renal Insufficiency, Chronic, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerumoxytolDrug
Also called Feraheme
Each 20 mL single-use vial contains 17 mL of ferumoxytol that consists of iron at a concentration of 30 mg Fe/mL, coated with polyglucose sorbitol carboxymethylether and formulated with mannitol, at a concentration of 44 mg/mL, in a black to reddish brown sterile, aqueous, colloidal, isotonic solution.
Iron sucroseDrug
Also called Venofer
Each mL contains 20 mg of elemental iron as iron sucrose in water for injection. The 5 mL single-use vial contains 100 mg of iron per 5 mL. The drug product contains approximately 30% sucrose (300 mg/mL).
| Study group | Role | What they receive |
|---|---|---|
| Ferumoxytol | Experimental | Not described Receives: Drug: Ferumoxytol |
| Iron sucrose | Active comparator | Not described Receives: Drug: Iron sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin change of at least 0.5 g/dL from Baseline to Week 5
Proportion of patients achieving a hemoglobin change of at least 0.5 g/dL during the period from Baseline to Week 5
Measured: 35 days
Secondary outcomes (2)
Incidence of Treatment Emergent Adverse Events
Incidence of Treatment Emergent Adverse Events
Measured: 49 days
Incidence of adverse events of special interest (AESI)
Incidence of adverse events of special interest (AESI) (hypotension and hypersensitivity)
Measured: 49 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start13 Aug 2018
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease; Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AMAG Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619850
- Sponsor's protocol ID
- AMAG-FER-CKD-354
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2018
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No